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Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)

2017年5月25日 更新者：GlaxoSmithKline

A Randomized, Open Label, Multicentre Study to Compare the Pharmaco-economic Implications of an Analgesia Based Regimen With Remifentanil and a Conventional Sedation Based Regimen Using Propofol in Medical and Post-surgical ICU Subjects Requiring Mechanical Ventilation for at Least 2 Days.

This study will be a multicentre randomized, open-label, phase IIIb study. This study will evaluate two different techniques of sedation: an analgesia based regimen with remifentanil versus a conventional sedation based regimen using propofol in subjects that require mechanical ventilation for at least 2 days in the ICU. The conventional sedation based regimen will consist of propofol combined with an opioid according to routine clinical practice (morphine, fentanyl, sufentanil or other as required) . The analgesia based regimen will consist of remifentanil, with propofol added on if required.

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

39

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 意大利
    • Calabria
      • Catanzaro、Calabria、意大利、88100
        • GSK Investigational Site
    • Campania
      • Napoli、Campania、意大利、80131
        • GSK Investigational Site
    • Emilia-Romagna
      • Ferrara、Emilia-Romagna、意大利、44100
        • GSK Investigational Site
    • Friuli-Venezia-Giulia
      • Udine、Friuli-Venezia-Giulia、意大利、33100
        • GSK Investigational Site
    • Lazio
      • Roma、Lazio、意大利、00161
        • GSK Investigational Site
    • Sicilia
      • Palermo、Sicilia、意大利、90127
        • GSK Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation.
  • Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug.
  • Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic agent and an opioid.

Exclusion Criteria:

  • Diagnosis: cardiopulmonary resuscitation (CPR) in the previous 24 hours or expecting to require major surgery within the next three days
  • Subject who, in the judgement of the investigator, has a life expectancy of 2 days or refrained or refuses full life support, which would limit the care provided

  • Concurrent medications:

    • Requires or is likely to require neuromuscular blocking agents by continuous infusion to facilitate mechanical ventilation
    • Has or is likely to receive an epidural block during the treatment period

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：异丙酚
异丙酚输液
药品：Propofol
conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical
实验性的：Remifentanil
remifentanil
药品：Remifentanil
analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)
大体时间：Up to 38 days (912 hours)
Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).
Up to 38 days (912 hours)
Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)
大体时间：Up to 38 days (912 hours)
Time from start of mechanical ventilation until actual extubation.
Up to 38 days (912 hours)
Duration of Time on Mechanical Ventilation (Per-Protocol Population)
大体时间：Up to 38 days (912 hours)
Time from start of mechanical ventilation until actual extubation
Up to 38 days (912 hours)

次要结果测量

结果测量
措施说明
大体时间
Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator's Decision)
大体时间：Up to 38 days (912 hours)
Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.
Up to 38 days (912 hours)
Duration of Extubation
大体时间：up to 38 days (912 hours)
Duration of extubation was measured.
up to 38 days (912 hours)
Duration of Weaning
大体时间：up to 38 days (912 hours)
Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.
up to 38 days (912 hours)
Duration of Remifentanil Infusion (ITT Population)
大体时间：Up to 10 days (240 hours)
Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Up to 10 days (240 hours)
Duration of Propofol Infusion (ITT Population)
大体时间：up to 10 days (240 hours)
Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
up to 10 days (240 hours)
Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)
大体时间：up to 10 days (240 hours)
Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
up to 10 days (240 hours)
Dose of Remifentanil Administered - Continuous Infusion
大体时间：Up to 10 days
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Up to 10 days
Doses of Sufentanil and Fentanil Administered - Continuous Infusion
大体时间：up to 10 days
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
up to 10 days
Dose of Propofol Administered - Continuous Infusion
大体时间：Up to 10 days
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Up to 10 days
Dose of Morphine Administered - Continuous Infusion
大体时间：up to 10 days
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
up to 10 days
Total Dose of Propofol Administered - Bolus
大体时间：Up to 10 days
Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Up to 10 days
Total Dose of Fentanil Administered - Bolus
大体时间：Up to 10 days
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Up to 10 days
Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale
大体时间：Up to 38 Days
Data from participants in the study for which the Sedation-Agitation Scale (SAS) and Pain Intensity (PI) were recorded were analyzed. "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. "Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
Up to 38 Days
Sedation-Agitation From Screening Through the End of Study
大体时间：Up to 38 days
"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
Up to 38 days
Sedation-Agitation for Day 7
大体时间：Day 7
"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
Day 7
Sedation-Agitation From Day 8 to Day 10
大体时间：Days 8, 9, and 10
"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
Days 8, 9, and 10
Number of Participants Analyzed for BIS (Bispectral Index Scale)
大体时间：Up to 38 days
Participants in the study for which BIS were evaluated. The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Up to 38 days
Bispectral Index (BIS)
大体时间：Screening through End of Study, up to 38 days
The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Screening through End of Study, up to 38 days
Bispectral Index (BIS) for Day 5
大体时间：Day 5
The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Day 5
Bispectral Index (BIS) for Extubation Period and Post-Extubation Period
大体时间：up to 38 days
The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
up to 38 days
Pain Intensity (PI)
大体时间：Up to 38 days
"Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
Up to 38 days
Pain Intensity From Day 8 to Day 10
大体时间：Days 8, 9, and 10
"Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
Days 8, 9, and 10

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

GlaxoSmithKline

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年11月1日

初级完成 (实际的)

2008年8月1日

研究完成 (实际的)

2008年9月1日

研究注册日期

首次提交

2007年2月15日

首先提交符合 QC 标准的

2007年2月15日

首次发布 (估计)

2007年2月19日

研究记录更新

最后更新发布 (实际的)

2017年5月30日

上次提交的符合 QC 标准的更新

2017年5月25日

最后验证

2017年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 108701

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